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NCT00693121 · ClinicalTrials.gov registry record · Phase 4
Amantadine for Treatment of Symptoms of the Post-traumatic Confusional State
A Phase 4 study, sponsored by Methodist Rehabilitation Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 79
- Enrollment target
NCT00693121 is a Phase 4 study that has completed, run by Methodist Rehabilitation Center. The registered enrollment target is 79 participants.
The verdict
NCT00693121, a Phase 4 study, has completed, sponsored by Methodist Rehabilitation Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 79 participants
- Enrollment target
Study Summary
Patients with traumatic brain injury often experience a period of acute confusion that may include agitation as they recover from their injuries. While this confusion generally resolves with time, patients may pose increased risk of injury to themselves or others during this period. Their behavior may also increase stress for family members and interfere with their ability to benefit from rehabilitation therapies. A number of different medications have been used to treat confusion to decrease agitation, decrease risk of injury, and improve participation in rehabilitation therapies. To this point, there has not been a research or scientific basis for knowing which medication is the best for a specific patient. The overall goal of this study is to conduct a scientific investigation to help determine which medication works best to treat confusion. Study hypothesis: Amantadine will reduce the severity and number of symptoms of acute confusion after traumatic brain injury.
Interventions
- DRUG Placebo capsule
- DRUG Amantadine hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2003-04 |
| Est. Completion | 2019-03 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00693121
The ClinicalTrials.gov registry entry for NCT00693121 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 79 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Methodist Rehabilitation Center, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo capsule is the first listed.
NCT00693121 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00693121 about?
NCT00693121 is a clinical study titled "Amantadine for Treatment of Symptoms of the Post-traumatic Confusional State". Patients with traumatic brain injury often experience a period of acute confusion that may include agitation as they recover from their injuries. While this confusion generally resolves with time, patients may pose increased risk of injury to themselves or others during this period. Their behavior m...
What is the current status of trial NCT00693121?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 79 participants. The study started on 2003-04. Estimated completion is 2019-03.
What interventions are being tested in trial NCT00693121?
The interventions under investigation include: Placebo capsule (DRUG), Amantadine hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00693121?
This trial is sponsored by Methodist Rehabilitation Center, which has 3 total clinical trials registered on ClinicalTrials.gov.
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